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Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels

University of British Columbia logo

University of British Columbia

Status

Completed

Conditions

HIV Infections
Atherosclerosis

Treatments

Drug: Placebo
Drug: Rosiglitazone maleate

Study type

Interventional

Funder types

Other

Identifiers

NCT00143624
CTN 178
P02-0086

Details and patient eligibility

About

This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat).

Participants will be randomly assigned to one of two groups: the first group will receive 8 mg of the study drug and the second group will be given a placebo, though neither group will know which formulation they are receiving. The study will follow both groups for one year, during which it will measure changes in blood vessel composition and activity, sugar metabolism, concentration of blood fat, and body fat distribution. This single-site study aims to enroll 50 participants.

Enrollment

50 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HIV-positive
  • Between 30 and 70 years of age
  • Elevated blood levels of fat
  • On two or more anti-HIV drugs for at least12 months in a row and unlikely to change anti-HIV therapy during the study
  • On stable regimen for at least 6 months for women taking oral contraceptive agents or hormone replacement
  • On a stable regimen for at least 6 months for men on testosterone replacement
  • If taking nevirapine, on therapy for at least 3 months with stable liver function tests

Exclusion criteria

  • Pregnancy and breastfeeding
  • Poorly controlled diabetes
  • Uncontrolled hypertension or clinical evidence of heart failure
  • Any serious medical conditions, including an active AIDS-defining condition, pancreatitis, or hepatitis within 6 months prior to the study
  • Laboratory abnormalities (see investigator)
  • On lipid lowering agents, insulin, anabolic steroids (except for testosterone at replacement doses), oral corticosteroids at greater than replacement doses, or growth hormones
  • History of liver reaction or severe edema associated with current thiazolidinedione
  • History of hypersensitivity to thiazolidinedione

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
The first group will receive 8 mg of the study drug (rosiglitazone).
Treatment:
Drug: Rosiglitazone maleate
2
Placebo Comparator group
Description:
The second group will be given a placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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